Definition: In Children With Or At Risk Of Developing Thoracic Insufficiency Syndrome, The Expandable Rib Prosthesis Devices Mechanically Stabilize And/or Correct Thoracic Deformities To Allow The Chest And Lungs To Grow. The Devices Are Attached Perpendicularly
| Device Type ID | 4721 |
| Device Name | Prosthesis, Rib Replacement |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | MDI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4721 |
| Device | Prosthesis, Rib Replacement |
| Product Code | MDI |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 84 |
Break | 38 |
Migration Or Expulsion Of Device | 18 |
Unintended Movement | 7 |
Device Operates Differently Than Expected | 3 |
Device Dislodged Or Dislocated | 2 |
Material Fragmentation | 2 |
Noise, Audible | 1 |
Appropriate Term/Code Not Available | 1 |
Difficult To Remove | 1 |
| Total Device Problems | 157 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes (USA) Products LLC | II | Aug-31-2015 |